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Knect365 is looking for 5-6 panellists, comprised of suppliers, manufacturers and regulators to join this breakfast surgery. Attendees will have the opportunity to submit their ‘pinch’ points anonymously to the panel in advance and this session will provide the perfect opportunity to hear from the experts on expectations

Affinity interaction based resins are the foundation for the platform purification of many different biological molecules. While some AAV affinity resins have existed for more than a decade, the growth in the AAV field now demands a true pan-affinity workhorse, analogous to Protein A for mAbs. In this work we investigate POROS CaptureSelect AAVX (AAVX) for the purification of various serotypes from both crude and pure feed streams. Performance of AAVX is directly compared against other commercially available AAV affinity resins. We evaluate binding capacities, binding kinetics, product recovery, impurity clearance, washing and elution strategies, cleanability, cyclability, regeneration as well as the scalability and suitability of the new resin for commercial manufacturing. The results demonstrate that the new AAVX resin is a robust option for the scalable, platform purification of various rAAV capsids from crude feed streams.

Daniel Hurwit -
Senior Associate Engineer,
Voyager Therapeutics, USA

More

10:05
-
10:25

Addressing the challenges of cell and gene therapy commercialization

The manufacturing of T cell and gene therapies is faced with multiple challenges that must be solved to create sustainable solutions to meet global commercialization requirements and quality standards. In addition to solutions for closed and automated manufacturing that improve safety and consistency, novel technologies are required to improve biological precision to utilize the potential of optimal T cell subsets in areas of unmet medical needs, such as solid tumors (90% of cancers).

Examples on how industry addresses these challenges will be discussed, including a solution that reduces variability in the biological starting material by simultaneous isolation and activation of naïve and early memory T cells with a demonstrated capacity to persist in vivo. This step is particularly important in autologous therapies where the quality of the patient’s T cells vary heavily with the disease and prior therapies. Moreover, solutions to improve productivity and scalability will be presented, including a xeno-free serum replacement that eliminates the use of human serum, a novel viral vector production system that enhances productivity, and a rapid time-to-result Mycoplasma detection kit that supports in-process monitoring during T cell manufacturing, release of critical raw materials (e.g. CAR vector) and batch release.

It also screens TCR candidates based on these targets against off-target

toxicities in absence of reliable in vivo models

Natural and engineered TCRs against these tumor targets have been used

in various Immatics’ Adoptive Cellular Therapy programs in “First In Man”

clinical trials

Extensive process development was carried out using primary T cells

derived from multiple healthy donors and cancer patients to optimize

each step in the manufacturing of TCR T cells for 3 clinical trials (IMA101,

IMA201, IMA202, and IMA203)

Manufacturing for engineered TCR T cell therapies has been adapted into

3 different closed systems with for future phases of clinical trials with

excellent results

Ali Mohamed -
CMC Vice President,
Immatics US Inc,

More

12:15
-
12:30

Info

How to support and improve CAR-T process performance through advanced data analytics

With the growing interest in CAR-T processing, the industry is looking for more process understanding, which can be achieved using advanced data analytics. The nature of the process, from leukapheresis to vector manufacturing, can be a cause of variation, which might impact the patient response. In this talk opportunities for using Multivariate Data Analysis and Design of Experiments during the different stages of the CAR-T manufacturing process are discussed.

Routine automated manufacture of CAR-T cell products in a closed system

Using closed system manufacturing reduces the risks of contamination and the requirements for in process controls and clean room infrastructure. Using the example of CAR T cell-based immunotherapies, I will demonstrate how production of cell products can be fully automated in a single-use closed system, the CliniMACS Prodigy®. Routine manufacture of CAR T products has been established at a new state-of-the-art Cell Factory and the automated procedure has been transferred to a number of other sites in a robust manner. The use of closed systems and automation has allowed an easy establishment of robust processes at academic institutes and paves the way for an effective scaling out of these procedures for commercialization.

A major hurdle to scale up the market of cell therapies is the cost and complexity of the workflow. We propose a novel approach based on a standardised workflow which will be easy to use, reliable and reproducible. Using silicon chip technology, fully integrated solutions can be built, combining microfluidics, photonics-based biosensors, PCR, and single cell manipulation. We will present a portfolio of technologies which will be the building blocks for bioprocessing and delivery of future personalised therapies.

The use of improved traditional GMP manufacturing techniques contributes to the success of Large Scale State-of-the-Art production of EMA-approved Cartilage Substitute

Recent advancements in several different fields of Advanced Therapies manufacturing showed an increasing demand for new, enhanced, effective processing and expansion methods, aimed at reducing the impact of the COGS in the development, adoption and finally commercialization of ATMPs.

Moreover, discovery and clinical proof of different, improved treating methods for certain diseases, opens demand for having available high quantities of a given product, impacting on and challenging the production capacity for suitable and successful scale-up.

The approach described here, while not changing the process as initially developed and approved by the regulatory authorities for low-scale production, addresses the issues above, boosting the production capabilities in a brand-new full GMP-compliant designed plant. Using isolation technology, a new modular and flexible approach for large quantities incubation, an accurate matching between the low- and large-scale process steps, a significant level of process automation (both in worklist and patient material management) and finally, a complete top-class track&trace software control and management system, the plant will be able to deliver the required doses of the ATMP drug (several thousand patients per year), under full respect of all the quality and regulatory issues.

Knect365 is looking for 5-6 panellists, comprised of suppliers, manufacturers and regulators to join this breakfast surgery. Attendees will have the opportunity to submit their ‘pinch’ points anonymously to the panel in advance and this session will provide the perfect opportunity to hear from the experts on expectations

Affinity interaction based resins are the foundation for the platform purification of many different biological molecules. While some AAV affinity resins have existed for more than a decade, the growth in the AAV field now demands a true pan-affinity workhorse, analogous to Protein A for mAbs. In this work we investigate POROS CaptureSelect AAVX (AAVX) for the purification of various serotypes from both crude and pure feed streams. Performance of AAVX is directly compared against other commercially available AAV affinity resins. We evaluate binding capacities, binding kinetics, product recovery, impurity clearance, washing and elution strategies, cleanability, cyclability, regeneration as well as the scalability and suitability of the new resin for commercial manufacturing. The results demonstrate that the new AAVX resin is a robust option for the scalable, platform purification of various rAAV capsids from crude feed streams.

The manufacturing of T cell and gene therapies is faced with multiple challenges that must be solved to create sustainable solutions to meet global commercialization requirements and quality standards. In addition to solutions for closed and automated manufacturing that improve safety and consistency, novel technologies are required to improve biological precision to utilize the potential of optimal T cell subsets in areas of unmet medical needs, such as solid tumors (90% of cancers).

Examples on how industry addresses these challenges will be discussed, including a solution that reduces variability in the biological starting material by simultaneous isolation and activation of naïve and early memory T cells with a demonstrated capacity to persist in vivo. This step is particularly important in autologous therapies where the quality of the patient’s T cells vary heavily with the disease and prior therapies. Moreover, solutions to improve productivity and scalability will be presented, including a xeno-free serum replacement that eliminates the use of human serum, a novel viral vector production system that enhances productivity, and a rapid time-to-result Mycoplasma detection kit that supports in-process monitoring during T cell manufacturing, release of critical raw materials (e.g. CAR vector) and batch release.

With the growing interest in CAR-T processing, the industry is looking for more process understanding, which can be achieved using advanced data analytics. The nature of the process, from leukapheresis to vector manufacturing, can be a cause of variation, which might impact the patient response. In this talk opportunities for using Multivariate Data Analysis and Design of Experiments during the different stages of the CAR-T manufacturing process are discussed.

Using closed system manufacturing reduces the risks of contamination and the requirements for in process controls and clean room infrastructure. Using the example of CAR T cell-based immunotherapies, I will demonstrate how production of cell products can be fully automated in a single-use closed system, the CliniMACS Prodigy®. Routine manufacture of CAR T products has been established at a new state-of-the-art Cell Factory and the automated procedure has been transferred to a number of other sites in a robust manner. The use of closed systems and automation has allowed an easy establishment of robust processes at academic institutes and paves the way for an effective scaling out of these procedures for commercialization.

A major hurdle to scale up the market of cell therapies is the cost and complexity of the workflow. We propose a novel approach based on a standardised workflow which will be easy to use, reliable and reproducible. Using silicon chip technology, fully integrated solutions can be built, combining microfluidics, photonics-based biosensors, PCR, and single cell manipulation. We will present a portfolio of technologies which will be the building blocks for bioprocessing and delivery of future personalised therapies.

15:10 -
15:2515 mins

Info

Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success

The use of improved traditional GMP manufacturing techniques contributes to the success of Large Scale State-of-the-Art production of EMA-approved Cartilage Substitute

Marco Fadda -
R&D Specialist,
Comecer, Italy

Recent advancements in several different fields of Advanced Therapies manufacturing showed an increasing demand for new, enhanced, effective processing and expansion methods, aimed at reducing the impact of the COGS in the development, adoption and finally commercialization of ATMPs.

Moreover, discovery and clinical proof of different, improved treating methods for certain diseases, opens demand for having available high quantities of a given product, impacting on and challenging the production capacity for suitable and successful scale-up.

The approach described here, while not changing the process as initially developed and approved by the regulatory authorities for low-scale production, addresses the issues above, boosting the production capabilities in a brand-new full GMP-compliant designed plant. Using isolation technology, a new modular and flexible approach for large quantities incubation, an accurate matching between the low- and large-scale process steps, a significant level of process automation (both in worklist and patient material management) and finally, a complete top-class track&trace software control and management system, the plant will be able to deliver the required doses of the ATMP drug (several thousand patients per year), under full respect of all the quality and regulatory issues.